HUMAN TISSUE AND SPECIMEN USAGE AGREEMENT

THIS HUMAN TISSUE AND SPECIMENS USAGE AGREEMENT(“Agreement”) is entered into effective as of, by and between the Regents of the University of Minnesota, a Minnesota constitutional corporation, through its Medical School Anatomy Bequest Program (“University”), and, a (“Requester”).

RECITALS

Requesterhas submitted a proposal, dated , a copy of which is attached hereto as Exhibit A (“Proposal”), to the University of Minnesota Anatomy Bequest Proposal ReviewCommittee. In the Proposal, Requesterhas outlined its proposed use for education, research, or scientific advancement, of certain cadaver body parts and tissues which University has received through its Anatomy Bequest Program (“Human Tissue and Specimens”).

The University of Minnesota Anatomy Proposal Review Committeehas approved Requester’s Proposal and is willing to allow Requester to use the Human Tissue and Specimens for the purposes stated in the Proposal and in accordance with the terms and conditions contained in this Agreement.

NOW, THEREFORE, the parties agree as follows:

1.Term of Use. Subject to the terms and conditions of this Agreement, Requester may use the Human Tissue and Specimens during the period commencing on and ending on , unless sooner terminated as set out in section 12 below. In the event Requester has proposed a long term loan of human anatomical material, Requester agrees to sign and abide by the Anatomy Bequest Program Human Anatomical Material Long Term Loan Policy.

2.Incorporation of Proposal. Requester may use the Human Tissue and Specimens only for the purposes stated in its Proposal and for no other purpose whatsoever.

3.Compliance with Conditions of Use, Policies, Procedures, and Laws and Regulations. Special conditions of use, if any, are attached hereto as Exhibit Band incorporated herein. Requester shall comply with such special conditions, if any. Requester also shall comply with the policies and procedures regarding third party use of Human Tissue and Specimens, attached hereto and incorporated herein as Exhibit C; and all applicable state and federal laws and regulations (“Laws”) regarding Human Tissue and Specimens, including Laws relating to transportation, storage, and treatment upon the conclusion of the use. No refunds will be allowed for donor specimens that were requested but not used during the study. Additionally, the Anatomy Bequest Program will not be able to support requests for the retention of any unused specimens.

4.Indemnification. Requester shall defend, hold harmless, release and indemnify University and each of its Regents, officers, employees, and agents (each referred to as a “University Indemnitee”) from and against any and all claims, actions, judgments, damages, liabilities, and expenses (including, but not limited to, reasonable attorneys’ and investigative fees) imposed upon, incurred by or asserted against a University Indemnitee directly or indirectly arising from or relating to Requester’s use of the Human Tissue and Specimens; provided, however, that Requester shall not be liable under this indemnity for any portion of such claims, actions, judgments, damages, liabilities, or expenses caused by a University Indemnitee’s intentional, wanton, or willful conduct.

5.Cost Recovery. Requester shall reimburse University for University’s costs of providing the Human Tissue and Specimens as set forth on Exhibit D. Payment shall be due within thirty (30) days from date of invoice.

6.Assignment.Requestermay not assign this Agreement in whole or in part, by operation of law or otherwise, without University’s prior express written consent. Any such permitted assignment will not, in any event, release Requester from its obligations hereunder.

7.Notices. Except as otherwise provided in this Agreement, all notices hereunder must be in writing and will be deemed given when mailed, or when delivered, if notice is given in any other manner, to the address of the party designated below or such other address as the party may designate by written notice to the other party. The date of mailing will be deemed to be the date appearing on the postmark.

If to University:University of MinnesotaMedicalSchool

Attn: Anatomy Bequest Program

3-005 Nils Hasselmo Hall

312 Church Street SE

Minneapolis, MN55455

With a copy to:University of Minnesota

Office of the General Counsel

Attn: Transactional Law Services Group

360 McNamara Alumni Center

200 Oak Street S.E.

Minneapolis, MN 55455-2006

E-mail:

If to Requester:

Attn:

Phone no.:

E-mail:

8.Amendments and Waiver. This Agreement may be amended only in a writing signed by both parties, unless a different means of amendment is expressly provided for herein. Any such written amendment must be signed, in the case of University, by its Vice President for Clinical Affairs and Dean of the Medical School, AcademicHealthCenter, or their delegatee.

9.Exhibits. The following Exhibits are attached to this Agreement and incorporated by reference herein:

9.1Exhibit A Requester’s Proposal

9.2Exhibit B Special Conditions of Use

9.3Exhibit C Policies and Procedures

9.4Exhibit D Cost Reimbursement Schedule

10.Relationship of Parties. No agency, partnership or joint venture is created by this Agreement. The parties disclaim any intent to form such relationships. In the event Requester desires to use any University facility in connection with its use of Human Tissue and Specimens, Requester shall sign a separate agreement relating to such use.

11.No Warranty. University makes no warranty whatsoever as to the fitness or sufficiency of the Human Tissue and Specimens, and Requester assumes all responsibility and liability therefore. IN THE EVENT REQUESTER COMES UPON University PREMISES IN CONNECTION WITH THIS AGREEMENT, REQUESTER HEREBY WAIVES ANY AND ALL CLAIMS IT MAY OTHERWISE HAVE MADE FOR DAMAGES FOR PERSONAL INJURY AND/OR PROPERTY DAMAGE, EXCEPT WHEN SUCH DAMAGE IS CAUSED DIRECTLY AND SOLELY BY UNIVERSITY’S GROSS NEGLIGENCE.

12.Termination.

12.1Requester may terminate this Agreement without cause as follows:

12.1.1If a study requesting human anatomical specimens from the Anatomy Bequest Program is cancelled seven (7) or fewer daysprior to the scheduled study- a cancellation fee of ten percent (10%) of the specimen reimbursement charges will be invoiced.

12.1.2If a study requesting human anatomical specimens from the Anatomy Bequest Program is cancelled two (2) or fewer days prior to the scheduled study-a cancellation fee of one hundred percent (100%) of the specimen reimbursement charges will be invoiced.

12.1.3The specimen reimbursement charges are published on the reimbursement fee schedule and exclude the estimated transportation charges unless the transportation actually occurred.

12.2Requester may terminate this Agreement for cause as follows:

12.2.1If a donor specimen does not suit the purpose of the study because of donor pathology interference and the disease or condition in question was not disclosed as a contraindication on the Anatomy Bequest Program Proposal Form, Requester will be responsible for the full specimen reimbursement fee.

12.2.2In the event that a donor with a known pathology which had previously been disclosed as contraindicated on the Anatomy Bequest Program Proposal Form is inadvertently assigned to a study, the Anatomy Bequest Program will not invoice the end user for the anatomy access or any associated transportation charges.

12.3University may terminate this Agreement at any time upon seven (7) days written notice to Requester.

13.Entire Agreement. Except as expressly provided herein, this Agreement constitutes the entire agreement with respect to the transactions contemplated herein and supersedes and is in full substitution for any and all prior agreements and understandings between the parties hereto relating to such transactions. Each party disclaims reliance on any prior oral or written representations or undertakings by the other party in entering into this Agreement unless such representations or undertakings are expressly set forth in this Agreement. Wherever the parties agree to discuss a matter, there will be no implied agreement to agree, nor will any other standard be applied in determining a party’s performance that is not expressly set forth in this Agreement. This Agreement may be signed in multiple counterparts which, taken together, constitute a single agreement. This Agreement and any amendment to it may be signed electronically, and such electronic signature will have the same effect as an original, provided the circumstances do not indicate otherwise.

14.Governing Law. The laws of the State of Minnesota shall govern the validity, construction and enforceability of this Agreement, without giving effect to its conflict of laws principles. Any dispute arising out of or related to this Agreement shall be brought in the state or federal court located in Hennepin County, Minnesota.

IN WITNESS WHEREOF, the parties have executed this Agreement on the day and date first written above.

Regents of the University of Minnesota
By:
Name:
Title:
Date: / By:
Name:
Title:
Date:

FORM: OGC-SC130

Form Date: 05.21.10

Form Revision Date: 10.09.18

1

Exhibit A

Requester’s Proposal

FORM: OGC-SC130

Form Date: 05.21.10

A-1

Exhibit B

Special Conditions of Use

FORM: OGC-SC130

Form Date: 05.21.10

B-1

Exhibit C

Policies and Procedures

Policies and Procedures Regarding

the Use of Human Anatomical Material

An Anatomy Bequest Program Proposal Form must be completed by the requestor and submitted to the Anatomy Bequest Program via email to prior to human anatomy access. The proposal is valid for three (3) years from the date of submittal. A proposal form is not required for any subsequent uses which occur within the three (3) year period for the same specific use. Any revisions to the proposal will require the submittal of a new proposal form and review by the review committee.

All aspects of the proposal submittal process, including the contents of the written proposal, will be held as confidential by the members of the Anatomy Bequest Program Proposal Review Committee, to the extent permitted by law.

All submitted Anatomy Bequest Program Proposal Forms will be reviewed by the Anatomy Bequest Program Proposal Review Committee to determine that each proposed use has scientific merit and is consistent with the disclosed uses published on the Anatomy Bequest Program consent documents.

The requester will be contacted with the results of the Anatomy Bequest Program Proposal Committee’s findings.

If the request is approved, requester will receive access to the anatomical specimens as a loan from the Anatomy Bequest Program. Human anatomical material is not sold. Specimen reimbursement fees are structured to compensate the Anatomy Bequest Program for expenses associated with the acquisition, preparation, tracking, storage and final disposition of whole body donors for use in medical education and research.

Requesters must agree to the use as defined in the Anatomy Bequest Program Proposal Form. The human specimens are only for the purpose herein described, and the requester will assume all responsibility for such use.

Appropriate respect and privacy of the donor must be maintained at all times during the time the human anatomical material is being used by the requestor.

Videotaping or photographing the human anatomical material is strictly prohibited without the prior consent of the Anatomy Bequest Program Proposal Review Committee, including but not limited to any images which will published or distributed.

The requesting organization shall track all loaned human anatomical material by keeping the donor’s acquisition number tag with the human anatomical material at all times during the loan. If the tag becomes disassociated from the human anatomical material, the Anatomy Bequest Program should be contacted immediately.

The custody of the human anatomical material shall not be transferred to any user not approved by the Anatomy Bequest Program Proposal Review Committee.

The Anatomy Bequest Program will arrange for final disposition of all human anatomical material. Human anatomical material received from the Anatomy Bequest Program shall not be disposed of as medical waste. All human anatomical material, including any histological slides prepared from human anatomical material received from the Anatomy Bequest Program, must be returned to the Anatomy Bequest Program as soon as the studies have been completed.

All persons involved in the course/study, or with knowledge of the course/study, must keep confidential all aspects of the study and information related to the human tissues that are a part of the course/study.

Any publications resulting from the access of human anatomical material received from the Anatomy Bequest Program should be forwarded to the Anatomy Bequest Program in a timely manner.

The requestor is responsible for making sure that each student or study participant has received an orientation prior to human anatomical material access. After completion of the orientation, each course/study participant must sign a Human Anatomy Access Orientation Disclosure Form. The forms shall be maintained by the requestor and are subject to review at any time the Anatomy Bequest Program requests.

Non-compliance with the above policies may result in termination of current loan, immediate return of the anatomical material, and denial of all future loan requests.

FORM: OGC-SC130

Form Date: 05.21.10

C-1

Exhibit D

Cost Reimbursement Schedule

FORM: OGC-SC130

Form Date: 05.21.10

D-1